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FDA Crackdown on Compounding Pharmacies

Posted by Jane Akre
Thursday, January 10, 2008 11:29 AM EST
Category: Major Medical, Protecting Your Family
Tags: Toxic Substances, FDA and Prescription Drugs, Defective and Dangerous Products


FDA is cracking down on compounding pharmacies that make bio-identical hormones for women after menopause.  This after Wyeth encouraged a crackdown.



The FDA is telling seven compounding pharmacies making bio-identical hormones for menopausal women to stop making false claims often online.

Compounding pharmacies make substantially similar hormones using natural substances and are heralded by celebrities such as Suzanne Somers as a safer alternative to prescription hormone replacement therapy (HRT). 

Many women stopped taking HRT after a 2002 landmark study found that the drugs may raise a woman’s risk of heart attack, stroke or breast cancer.

Since then many pharmacies have emerged that make or “compound” their own drugs that may be customized to a woman’s specific hormonal needs based on the results of a saliva test. Doctors who refer patients to compounding pharmacies may be paying more attention to their patients, an added component of their popularity.

Ironically, commercial drug companies may also be using bio-identical hormones derived from estradiol or progesterone.  Hormones sold by compounding pharmacists are often called “bio-identical” because they are derived from plants, such as yams, that closely match hormones made by the woman’s body.

The FDA says that the pharmacies, many of which are online, are making additional false claims such the drugs ability to treat Alzheimer’s disease, stroke and cancer and their superiority to prescription drugs.  Compounding pharmacies are regulated by states, not the FDA.

The FDA warns consumers that a hormone is a hormone and has the same risks no matter where it comes from. The agency is also concerned about an unapproved hormone substitute, estriol that many compounding pharmacies use. The drug is approved in many European countries but not the U.S.

Interestingly the FDA began the crackdown after hormone maker, Wyeth asked the agency to take action. Wyeth makes Premarin and Prempro and saw sales cut in half after the 2002 study.

The International Academy of Compounding Pharmacists (IACP)  has issued a statement as a result of the FDA's action saying,  “Under this policy, patients will suffer while Wyeth profits.”

L.D. King, executive director writes, “Thousands of doctors are making patient-by-patient decisions that compounding hormones are medically appropriate, sometimes because Wyeth’s products are found to be ineffective or produce side effects. This is a decision that should be left to doctors. Pharmacy compounding is a long-standing, state-regulated and medically vital practice. Millions of Americans have unique health needs that off-the-shelf prescription medicines cannot meet. For them, customized, compounded medications prescribed or ordered by licensed physicians and veterinarians and mixed safety by trained, licensed compounding pharmacists are the only way to better health.” #


Anonymous User
Posted by Plant lover
Friday, January 11, 2008 1:53 AM EST

Every now and then the FDA gets to big for its britches and needs to be put in its place. Good luck they are an 800 pound gorilla but I hope you win.

Posted by Jeffrey Dach MD
Sunday, January 20, 2008 3:52 PM EST

It is obvious that the FDA has been waging a war
against bioidentical hormones because of a citizen's petition from Wyeth.

Wyeth makes the synthetic hormone, prempro, a drug found to cause cancer and heart disease in the WHI study published in JAMA July 2002.

Wyeth has lost 2 billion in sales since millions of women have switched away from the Wyeth product to compounded bioidentical hormones, a safer and more effective alternative.

Wyeth wants to use the FDA to eliminate its competition.

The problem is that the FDA does not regulate compounded bioidentical hormones, the states do the regulation.

And the FDA's actions have only demonstrated that the agency is completely inept and corrupted by special interest groups in the drug industry.

To read more about this click here,

FDA Declares War on BioIdentical Hormones
by Jeffrey Dach MD

Posted by FDA Declares War on BioIdentical Hormones
Sunday, January 20, 2008 3:54 PM EST

Click on URL Title above for link to full article

Jeffrey Dach MD

Comments for this article are closed.

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